NCT05757518

Brief Summary

The main goal of this study was to investigate the effectiveness of cryo-sauna in preventing the development of DOMS in the lower extremity. The second goal is to analyze the rate of regenerative changes in the right muscles after acute fatigue-induced exercises.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 16, 2023

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2023

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2023

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

February 11, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

March 7, 2023

Completed
Last Updated

March 7, 2023

Status Verified

March 1, 2023

Enrollment Period

4 days

First QC Date

February 11, 2023

Last Update Submit

March 3, 2023

Conditions

Injury;Sports

Keywords

DOMSinjury preventionperformancemuscle properties

Outcome Measures

Primary Outcomes (4)

  • Measurement of muscle stiffness in the lower extremity.

    Stiffness \[N/m\] was measured on: the anterior thigh, posterior thigh, shin, and calf muscles in 23 reference points.

    Change from baseline muscle stiffness at 96 hours after fatigue-induced exercise.

  • Measurement of blood markers.

    Leukocytes \[10\^9 /L\] concentration.

    Change from baseline leukocytes concentration at 96 hours after fatigue-induced exercise.

  • Measurement of blood markers.

    Creatine kinase \[ng/mL\] concentration.

    Change from baseline creatine kinase concentration at 96 hours after fatigue-induced exercise.

  • Measurement of blood markers.

    Myoglobin \[ng/mL\] concentration.

    Change from baseline myoglobin concentration at 96 hours after fatigue-induced exercise.

Study Arms (2)

Experimental group

EXPERIMENTAL

Cryo-stimulation using cryosauna after fatigue-induced exercise.

Other: Cryosauna

Control group

NO INTERVENTION

Without any intervention after fatigue-induced exercise.

Interventions

CryosaunaOTHER

The intervention was Cryosauna - cryostimulation at -110°C for 1.5 minutes, for four consecutive days.

Experimental group

Eligibility Criteria

Age20 Years - 26 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • no previous experience with cryostimulation using a cryo-sauna,
  • recreational lifestyle.

You may not qualify if:

  • Current or prior pain or injury in the lower extremity.
  • Previous history of surgery in the lower extremity.
  • Cardiovascular disabilities.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Physical Exercise Laboratory

Gdansk, 80-336, Poland

Location

Related Publications (3)

  • Klich S, Krymski I, Michalik K, Kawczynski A. Effect of short-term cold-water immersion on muscle pain sensitivity in elite track cyclists. Phys Ther Sport. 2018 Jul;32:42-47. doi: 10.1016/j.ptsp.2018.04.022. Epub 2018 May 1.

    PMID: 29738892BACKGROUND

  • Klich S, Ficek K, Krymski I, Klimek A, Kawczynski A, Madeleine P, Fernandez-de-Las-Penas C. Quadriceps and Patellar Tendon Thickness and Stiffness in Elite Track Cyclists: An Ultrasonographic and Myotonometric Evaluation. Front Physiol. 2020 Dec 14;11:607208. doi: 10.3389/fphys.2020.607208. eCollection 2020.

    PMID: 33381054BACKGROUND

  • Kons RL, Orssatto LBDR, Sakugawa RL, da Silva Junior JN, Diefenthaeler F, Detanico D. Effects of stretch-shortening cycle fatigue protocol on lower limb asymmetry and muscle soreness in judo athletes. Sports Biomech. 2023 Sep;22(9):1079-1094. doi: 10.1080/14763141.2020.1779335. Epub 2020 Jul 9.

    PMID: 32644009BACKGROUND

MeSH Terms

Conditions

Athletic Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Sebastian Klich, Dr.

    University School of Physical Education in Wrocław

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Participants will be allocated to intervention (cryostimulation using cryosauna) or a control group (without any intervention) using a randomized list of allocated numbers generated by a computer program. The investigator and Outcomes Assessor will be blinded to the allocation process.
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Director

Study Record Dates

First Submitted

February 11, 2023

First Posted

March 7, 2023

Study Start

January 16, 2023

Primary Completion

January 20, 2023

Study Completion

January 31, 2023

Last Updated

March 7, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)